(135 days)
Not Found
No
The summary describes a digital stethoscope that filters and transmits audio. It mentions a software engine for managing the device and streaming audio, but there is no mention of AI or ML being used for analysis, interpretation, or diagnostic support beyond basic filtering. The "diagnostic decision support" mentioned in the intended use appears to refer to the device providing clear audio for the healthcare professional to interpret, not automated analysis by the device itself.
No
The device is described as aiding in physical assessment and diagnostic decision support, not providing treatment.
Yes
The device is intended for "diagnostic decision support" and is used to record sounds for the physical examination of patients with suspected diseases of various organ systems, which are all activities related to diagnosis.
No
The device description clearly outlines a physical "eKuore Pro 4T device" which is a hardware component designed for detecting and amplifying sounds, and which can be used as a standalone stethoscope. While there is a software component ("eKuore Pro 4T Engine"), the overall system includes dedicated hardware.
Based on the provided information, the eKuore Pro 4T is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- eKuore Pro 4T Function: The eKuore Pro 4T is a digital stethoscope. Its intended use is to listen to sounds within the patient's body (heart, lungs, etc.) during a physical examination. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "physical assessment of a patient" and to "record heart sounds and cardiac murmurs, bruits, respiratory sounds and abdominal sounds during physical examination." This is a direct physical assessment, not an in vitro test.
Therefore, the eKuore Pro 4T falls under the category of a medical device used for physical examination and diagnostic support based on auscultation, not an IVD.
N/A
Intended Use / Indications for Use
The eKuore Pro 4T is intended to be used as a part of a physical assessment of a patient by healthcare professionals for diagnostic decision support in clinical settings. eKuore Pro 4T is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to compatible software.
It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems.
Product codes
DQD
Device Description
eKuore Pro 4T is formed by eKuore Pro 4T device and eKuore Pro 4T Engine.
- eKuore Pro 4T allows use as standalone stethoscope and wireless audio transmission without smartphone to third party applications that uses eKuore Pro 4T Engine.
- eKuore Pro 4T Engine is a Java library that allows third party companies, communicate with eKuore Pro 4T device.
The main purpose of eKuore Pro 4T device is the detection and amplification of heart, lung, arteries, veins and internal sounds using selective frequency organ ranges.
The design of eKuore Pro 4T lets the user change the chestpiece attached between different sizes depend on the patient to be auscultated.
eKuore Pro 4T Engine Java is a Java library (.jar file) that provides management functionalities for an eKuore Pro 4T device. It provides these functionalities:
- Stream auscultation audio from an eKuore Pro 4T device in real-time, through a WLAN.
- Get and set additional information about the connected device:
- The battery level of the device
- The firmware version of the device
- The serial number of the device
- The volume level of the device
- The filter currently being used in the auscultation
- The hardware version of the device
- Configure the connection (IP, SSID, password, and ports) of the eKuore Pro 4T device with a router in a WLAN, allowing the device to autonomously reconnect to it when it is turned on again and stream audio.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart, lung, arteries, veins and internal organs (cardiac, vascular, pulmonary or abdominal organ systems).
Indicated Patient Age Range
pediatric and adult patients
Intended User / Care Setting
healthcare professionals for diagnostic decision support in clinical settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical test data are submitted to support this premarket notification and to establish the decision concerning adequate safety and performance of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
November 10, 2021
Chip Ideas Electronics S.L. Bernardo Plaza Regulatory Affairs Manager C/ Alfareria 3 B Burjasot, Valencia 46100 Spain
Re: K212013
Trade/Device Name: eKuore Pro 4T Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: October 1, 2021 Received: October 13, 2021
Dear Bernardo Plaza:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212013
Device Name
eKuore Pro 4T
Indications for Use (Describe)
The eKuore Pro 4T is intended to be used as a part of a physical assessment of a patient by healthcare professionals for diagnostic decision support in clinical settings. eKuore Pro 4T is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to compatible software.
It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Section 5 - 510(k) Summary
SUBMITTER
Submitter name: Submitter address:
Chip Ideas Electronics, S.L. C/ Alfarería 3 B. 46100 Burjasot, Valencia SPAIN
Registration Number: Owner Operator Number: 3017140534 10075275
Contact person: Phone: e-mail:
Bernardo Plaza Trillo +34 640742454 bernardo.plaza@ekuore.com
Date Prepared:
2021-10-14
DEVICE
Device Trade Name: Common Name: Regulation Name: Regulatory Class: Product Code: Regulation Number: eKuore Pro 4T ELECTRONIC STETHOSCOPE ELECTRONIC STETHOSCOPE Class II DQD 870.1875
PREDICATE DEVICE
eKuore Pro Series (K203007) Predicate Device (S):
4
Section 5 - 510(k) Summary
5.1 DEVICE DESCRIPTION
eKuore Pro 4T is formed by eKuore Pro 4T device and eKuore Pro 4T Engine.
- . eKuore Pro 4T allows use as standalone stethoscope and wireless audio transmission without smartphone to third party applications that uses eKuore Pro 4T Engine.
- eKuore Pro 4T Engine is a Java library that allows third party companies, . communicate with eKuore Pro 4T device.
The main purpose of eKuore Pro 4T device is the detection and amplification of heart, lung, arteries, veins and internal sounds using selective frequency organ ranges.
The design of eKuore Pro 4T lets the user change the chestpiece attached between different sizes depend on the patient to be auscultated.
eKuore Pro 4T Engine Java is a Java library (.jar file) that provides management functionalities for an eKuore Pro 4T device. It provides these functionalities:
- Stream auscultation audio from an eKuore Pro 4T device in real-time, ● through a WLAN.
- Get and set additional information about the connected device: ●
- o The battery level of the device
- The firmware version of the device o
- The serial number of the device o
- The volume level of the device o
- The filter currently being used in the auscultation O
- The hardware version of the device o
- Configure the connection (IP, SSID, password, and ports) of the eKuore Pro . 4T device with a router in a WLAN, allowing the device to autonomously reconnect to it when it is turned on again and stream audio.
5
eKuore Pro 4T 510(k) Premarket Notification
| Equipment description | |
|---|---|
| Image: eKuore Pro 4T main piece with the chestpiece attached | eKuore Pro 4T main piece with the chestpiece attached. |
| Image: Hand attaching chestpiece to eKuore Pro 4T | To use the eKure Pro 4T devices the chestpice must be attached and turn it on, as is shown in the pictogram. |
| There are three models of chestpiece depend on the patient to be auscultated. S, M or L from neonatal to adults patients. | |
| Image: Healthcare professional, Integration-Information, Software Sistem | eKuore Pro 4T device is connected via Wi-Fi to software built using eKuore Pro 4T engine. |
| Image: eKuore Pro 4T product packaging | eKuore Pro 4T product packaging. |
Section 5 – 510(k) Summary
Table 5.1 Equipment Description
The following table shows the difference and similarities of each eKuore Pro Series model:
| Characteristic | EP0002 | EP0099 | EP0098 |
|---|---|---|---|
| Form | Same for the three models | Same for the three models | Same for the three models |
| Design | Same for the three models | Same for the three models | Same for the three models |
| Material | Same for the three models | Same for the three models | Same for the three models |
| Function | For healthcare | For healthcare | For healthcare |
6
eKuore Pro 4T 510(k) Premarket Notification
Section 5 - 510(k) Summary
| | professionals | professionals that needs
increased volume | professionals |
|--------------------------|-----------------------------------------------|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Connectivity | Create an WLAN access
point | Create an WLAN access
point | It connects to an WLAN
access point Configurable
with eKuore Pro 4T Engine
Java library |
| Volume control /
gain | 5 steps, 2 dB of difference
between levels | 5 steps, 2 dB of difference
between levels with an
offset of +6db | 5 steps, 2 dB of difference
between levels |
| Energy Supply | | Same for the three models | |
| Software | Compatible with eKuore
Pro APP. | Compatible with eKuore
Pro APP. | No compatible with eKuore
Pro APP. Configurable with
eKuore Pro Engine Java
library |
| Firmware | eKuore Pro FW v1.10.07 | eKuore Pro FW v1.10.07 | eKP4T FW v1.0.4 |
| DSP configuration | v00.00.08 | v00.00.58 | v00.00.08 |
| Hardware | | Same for the three models | |
Table 5.2 - eKuore Pro models comparison table
The following table shows the technical characteristics of eKuore Pro 4T
| Weight without chestpiece | 85 gr |
|---|---|
| Dimensions without chestpiece | 13cm x 5cm x 3cm (W x D x H) |
| Weight with chestpiece | 150 gr |
| Dimensions with chestpiece | 13cm x 5cm x 5cm (W x D x H) |
| Working temperature and humidity | 0 to +40 °C and +15 to +93% |
| Transportation and storage temperature and | |
| humidity | -20 to +45°C and +15 to +93% |
| IP Rate | IP21 |
| Transmission frequency range | Beetween 2.412 GHz and 2.484 GHz |
| Modulation type | DSSS |
| Wireless quality of service | Device needs to be connected to wlan with at |
| least 705kbs | |
| Wireless security | WLAN WPA2 encrypted networks preferred. |
| Input voltage during the load | 5V DC, 500 mA |
| Power | 2,5 W |
7
eKuore Pro 4T 510(k) Premarket Notification
Section 5 - 510(k) Summary
| Battery | Rechargeable. 1400 mAh lithium polymer. Do
not replace by user |
|----------------------------|--------------------------------------------------------------------|
| USB Port | Do not connect while the device iss being used
with the patient |
| Wireless functions | Audio transmission |
| Wireless standard protocol | IEEE 802.11bg |
| Effective radiated power | 15dBm (32mW) |
Table 5.3 - eKuore Pro 4T technical characteristics
5.2 INDICATIONS FOR USE
The eKuore Pro 4T is intended to be used as a part of a physical assessment of a patient by healthcare professionals for diagnostic decision support in clinical settings. eKuore Pro 4T is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to compatible software.
It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems.
5.3 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The electronic stethoscopes are mainly used on auscultation in the detection of cardiac, respiratory sounds and check other internal organs. These types of devices are used to digitize the data of the auscultation into a mobile device.
In the establishment of substantial equivalence, eKuore Pro 4T compared to the predicate device K203007, eKuore Pro Series:
8
eKuore Pro 4T 510(k) Premarket Notification
Section 5 – 510(k) Summary
| Elements of
| comparison | New Device | Predicate device | Comparison | |
|---|---|---|---|---|
| eKuore Pro 4T | eKuore Pro | eKuore Pro Amplified | ||
| Regulatory Class | Class II | Class II | Class II | Identical to predicate device |
| Classification name | Electronic Stethoscope | Electronic Stethoscope | Electronic Stethoscope | Identical to predicate device |
| Regulation Number | 21 CFR 870.1875 | 21 CFR 870.1875 | 21 CFR 870.1875 | Identical to predicate device |
| Product code | DQD | DQD | DQD | Identical to predicate device |
| Manufacturer | Chip Ideas Electronics, SL. | Chip Ideas Electronics, SL. | Chip Ideas Electronics, SL. | Identical to predicate device |
| FDA Clearance | K212013 Pending | K203007 | K203007 | - |
| Indications for use | The eKuore Pro Series is intended | |||
| to be used as a part of a physical | ||||
| assessment of a patient by | ||||
| healthcare professionals for | ||||
| diagnostic decision support in | ||||
| clinical settings. eKuore Pro Series | ||||
| is intended for use on pediatric and | ||||
| adult patients. It can electronically | ||||
| filter and transfer sounds to | ||||
| compatible software. | ||||
| It can be used to record heart | ||||
| sounds and cardiac murmurs, bruits, | ||||
| respiratory sounds and abdominal | ||||
| sounds during physical examination | ||||
| in normal patients or those with | ||||
| suspected diseases of the cardiac, | ||||
| vascular, pulmonary or abdominal | ||||
| organ systems. | The eKuore Pro Series is intended | |||
| to be used as a part of a physical | ||||
| assessment of a patient by | ||||
| healthcare professionals for | ||||
| diagnostic decision support in | ||||
| clinical settings. eKuore Pro Series | ||||
| is intended for use on pediatric and | ||||
| adult patients. It can electronically | ||||
| filter and transfer sounds to | ||||
| compatible software. | ||||
| It can be used to record heart | ||||
| sounds and cardiac murmurs, bruits, | ||||
| respiratory sounds and abdominal | ||||
| sounds during physical examination | ||||
| in normal patients or those with | ||||
| suspected diseases of the cardiac, | ||||
| vascular, pulmonary or abdominal | ||||
| organ systems. | The eKuore Pro Series is intended | |||
| to be used as a part of a physical | ||||
| assessment of a patient by | ||||
| healthcare professionals for | ||||
| diagnostic decision support in | ||||
| clinical settings. eKuore Pro Series | ||||
| is intended for use on pediatric and | ||||
| adult patients. It can electronically | ||||
| filter and transfer sounds to | ||||
| compatible software. | ||||
| It can be used to record heart | ||||
| sounds and cardiac murmurs, bruits, | ||||
| respiratory sounds and abdominal | ||||
| sounds during physical examination | ||||
| in normal patients or those with | ||||
| suspected diseases of the cardiac, | ||||
| vascular, pulmonary or abdominal | ||||
| organ systems. | Identical to predicate device | |||
| Principles of operation | The device picks up sounds from a | |||
| patient's body. This sound is | ||||
| filtered, amplified and sent it to the | ||||
| user through earbuds, also it can be | ||||
| sent via WiFi to eKuore Pro 4T | The device picks up sounds from a | |||
| patient's body. This sound is | ||||
| filtered, amplified and sent it to the | ||||
| user through earbuds, also it can be | ||||
| sent via WiFi to compatible | The device picks up sounds from a | |||
| patient's body. This sound is | ||||
| filtered, amplified + 6dB offset and | ||||
| sent it to the user through earbuds, | ||||
| also it can be sent via WiFi to | Similar to predicate device | |||
| Elements of | ||||
| comparison | New Device | Predicate device | Comparison | |
| eKuore Pro 4T | eKuore Pro | eKuore Pro Amplified | ||
| Engine Java. | smartphones and tablets. | compatible smartphones and | ||
| tablets. | ||||
| Clinical conditions | Human body sounds related | Human body sounds related | Human body sounds related | Identical to predicate device |
| Use | Electronic stethoscope | Electronic stethoscope | Electronic stethoscope | Identical to predicate device |
| Prescription/O.T.C. | Prescription use | Prescription use | Prescription use | Identical to predicate device |
| Intended for Direct | ||||
| Connection to Patient | YES | YES | YES | Identical to predicate device |
| Use environment | Clinical settings | Clinical settings | Clinical settings | Identical to predicate device |
| Type of users | Health-care personnel | Health-care personnel | Health-care personnel with hearing | |
| difficulties | Identical to predicate device | |||
| Target population | Pediatric and adult patients | Pediatric and adult patients | Pediatric and adult patients | Identical to predicate device |
| Cleaning & | ||||
| Maintenance | When the power supply is off, the | |||
| entire plastic surface can be cleaned | ||||
| sliding an alcohol pad. Excess fluid | ||||
| during cleaning can cause leakage | ||||
| of moisture on internal components. | ||||
| Clean the stethoscope from patient | ||||
| to patient | When the power supply is off, the | |||
| entire plastic surface can be cleaned | ||||
| sliding an alcohol pad. Excess fluid | ||||
| during cleaning can cause leakage | ||||
| of moisture on internal components. | ||||
| Clean the stethoscope from patient | ||||
| to patient. | When the power supply is off, the | |||
| entire plastic surface can be cleaned | ||||
| sliding an alcohol pad. Excess fluid | ||||
| during cleaning can cause leakage | ||||
| of moisture on internal components. | ||||
| Clean the stethoscope from patient | ||||
| to patient | Identical to predicate device | |||
| TECHNICAL EQUIVALENCE | ||||
| Sound track transfer | ||||
| function | Yes | Yes | Yes | Identical to predicate device |
| Signal transmission | ||||
| for visualization | Wireless transmission to eKuore | |||
| Pro 4T Engine Java | Wireless transmission to compatible | |||
| smartphones/ tablet via WiFi | Wireless transmission to compatible | |||
| smartphones/ tablet via WiFi | Similar to predicate device. | |||
| Energy Source | Lithium-Ion Battery | Lithium-Ion Battery | Lithium-Ion Battery | Identical to predicate device |
| System required | Platform compatible with Java VM | Android device and Apple, Inc | Android device and Apple, Inc | Different to predicate device |
| Hardware and | ||||
| software platforms | Desktop or Mobile devices | Mobile devices or tables | Mobile devices or tables | Different to predicate device |
| Connections | Micro USB connector only to | |||
| charge the internal battery of the | ||||
| device | Micro USB connector only to | |||
| charge the internal battery of the | ||||
| device | Micro USB connector only to | |||
| charge the internal battery of the | ||||
| device | Identical to predicate device | |||
| Elements of | ||||
| comparison | New Device | Predicate device | Comparison | |
| comparison | eKuore Pro 4T | eKuore Pro | eKuore Pro Amplified | |
| Filter frequency range | • Heart (50-150 Hz) | |||
| • Lung (50-500 Hz) | ||||
| • Extended (40-600 Hz) | • Heart (50-150 Hz) | |||
| • Lung (50-500 Hz) | ||||
| • Extended (40-600 Hz) | • Heart (50-150 Hz) | |||
| • Lung (50-500 Hz) | ||||
| • Extended (40-600 Hz) | Identical to predicate device | |||
| Wireless data | ||||
| transmission | Audio and configuration | Audio | Audio | Different to predicate device |
| Signal Input Method | Sound waves collected via a | |||
| Transducer. Microelectro- | ||||
| mechanical microphone | Sound waves collected via a | |||
| Transducer. Microelectro- | ||||
| mechanical microphone | Sound waves collected via a | |||
| Transducer. Microelectro- | ||||
| mechanical microphone | Identical to predicate device | |||
| Audio Output Method | Earbuds connected with the device | |||
| through the 3.5mm Jack directly to | ||||
| the eKuore device or from the | ||||
| device running eKuore Pro 4T | ||||
| engine audio output | Earbuds connected with the device | |||
| through the 3.5mm Jack directly to | ||||
| the eKuore device or from the | ||||
| smartphone/tablet audio outputs | Earbuds connected with the device | |||
| through the 3.5mm Jack directly to | ||||
| the eKuore device or from the | ||||
| smartphone/tablet audio outputs | Similar to predicate device | |||
| Signal Storage | Depend on platform running | |||
| eKuore Pro 4T engine. | Depend on Smartphone/tablet | |||
| internal memory, eKuore Pro App | ||||
| lets the user record 30, 60, 90 or | ||||
| 120 seconds. eKuore Pro Series | ||||
| devices does not stored data. | Depend on Smartphone/tablet | |||
| internal memory, eKuore Pro App | ||||
| lets the user record 30, 60, 90 or | ||||
| 120 seconds. eKuore Pro Series | ||||
| devices does not stored data. | Different to predicate device | |||
| Performance | ||||
| requirements | Temp range: 0°C to +40°C | |||
| Humidity range: 15% to 93% | Temp range: 0°C to +40°C | |||
| Humidity range: 15% to 93% | Temp range: 0°C to +40°C | |||
| Humidity range: 15% to 93% | Identical to predicate device | |||
| BIOLOGICAL EQUIVALENCE | ||||
| Body material | ABS (Acrylonitrile Butadiene | |||
| Styrene) | ABS (Acrylonitrile Butadiene | |||
| Styrene) | ABS (Acrylonitrile Butadiene | |||
| Styrene) | Identical to predicate device | |||
| Diaphragm material | Membrane: Epoxy and Fiberglass | |||
| Membrane's ring: PVC | Membrane: Epoxy and Fiberglass | |||
| Membrane's ring: PVC | Membrane: Epoxy and Fiberglass | |||
| Membrane's ring: PVC | Identical to predicate device | |||
| Contact with human | ||||
| tissues or body fluids | The chestpiece is in contact with | |||
| patients' skin. | The chestpiece is in contact with | |||
| patients' skin. | The chestpiece is in contact with | |||
| patients' skin. | Identical to predicate device | |||
| Sterility | Not intended to be sterilized | Not intended to be sterilized | Not intended to be sterilized | Identical to predicate device |
9
eKuore Pro 4T 510(k) Premarket Notification
Section 5 - 510(k) Summary
10
eKuore Pro 4T 510(k) Premarket Notification
Section 5 - 510(k) Summary
Table 5.4. Substantial Equivalence Comparison – eKuore Pro Series and Predicate Device K203007
Rev 07
11
eKuore Pro 4T 510(k) Premarket Notification
Section 5 - 510(k) Summary
Information provided in these 510(k) submissions shows that eKuore Pro 4T is substantially equivalent to the predicate device eKuore Pro Series cleared under K203007 in terms of intended use, indications for use, compatibility, and technological characteristics. There are no new questions of safety or effectiveness.
Summary discussion of non-clinical data:
The proposed device has been designed, developed, tested, verified, and validated according to documented procedures and specific protocols in line with the following FDA guidance documents:
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
General requirements for basic safety standard requirements for medical electrical equipment test have been successfully complete following standard of AAMI ANSI ES 60601-1:2005 and A1:2012 and IEC 60601-1-2 Edition 4: 2014-02 as being equivalent to the predicate device.
Integration verification and validation testing have been successfully complete following standard IEC 62304:2015.
Usability testing requirements have been evaluated and successfully met as per standards AAMI ANSI IEC 62366:2007.
Design and development included identification, and control of potential hazards as per standard ISO 14971:2007.
Summary discussion of clinical data:
Non-clinical test data are submitted to support this premarket notification and to establish the decision concerning adequate safety and performance of the predicate device.
5.4 CONCLUSIONS
Based on the information provided in this premarket notification, Chip Ideas Electronics S.L., concludes that eKuore Pro Series is substantially equivalent to the listed legally marketed predicate device.